(96 days)
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No
The summary describes a standard ELISA assay for detecting antibodies, with no mention of AI or ML technologies.
No
The device is used for diagnostic purposes (detection of antibodies as an aid in diagnosing rheumatoid arthritis), not for treating a disease or condition.
Yes
The device is used as an "aid in the diagnosis of rheumatoid arthritis," which directly indicates its role in diagnosing a medical condition.
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and processes, not a software-only device.
Yes, based on the provided information, the QUANTA Lite™ CCP3 IgG ELISA is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is an "enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3... antibodies in patient sera or citrated or EDTA plasma." This involves testing biological samples in vitro (outside the body).
- Purpose: The purpose is to aid in the diagnosis of rheumatoid arthritis, which is a medical condition.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
NHX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows a partial view of a document with a logo on the left and some text on the right. The logo appears to be a stylized emblem, possibly representing a department or organization. To the right of the logo, there is text, but the specific content is not fully visible due to the image's cropping. The visible text seems to be part of a heading or title, with the letters 'DE' clearly discernible at the beginning of the line.
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Vice President 9900 Old Grove Rd. San Diego, CA 92131-1638
NOV 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K052264
Trade/Device Name: QUANTA Lite™ CCP3 IgG ELISA Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX Dated: August 18, 2005 Received: August 19, 2005
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K052264
Device Name: QUANTA Lite™ CCP3 IgG ELISA
Indications For Use:
The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(ODE)
Maria Chan
Division Sign-Off
Prescription Use_X_ Use (Per 21 CFR 801.109)
Office of In Vitro Diagnostic
Device Evaluation and Over-The-Counter
510(K) K052204
(Optional Format 1-2-96)